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Trial registered on ANZCTR


Registration number
ACTRN12610000835044
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
6/10/2010
Date last updated
6/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence on hemodynamics of conversion from Calcineurin Inhibitor to Sirolimus in Renal and Liver Transplant patients
Scientific title
Influence on hemodynamics of conversion from Calcineurin Inhibitor to Sirolimus in Renal and Liver Transplant patients older than 18 year
Secondary ID [1] 1031 0
Cochrane Renal Group, CRG110600099
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
renal allograft recipients or liver allograft recipients 243747 0
Condition category
Condition code
Renal and Urogenital 257188 257188 0 0
Kidney disease
Oral and Gastrointestinal 258409 258409 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Switch calcineurin inhibitor (CNI) to Sirolimus treatment;
Sirolimus dose:Loading dose 10-15 mg/d (at clinicians discretion); d 2-6:3-5 mg/d (at clinicians discretion), after d 7,sirolimus dosage was adjusted to target through level of 6–16 ng/mL
study duration: 1 year.
administration: oral capsule
Intervention code [1] 256203 0
Treatment: Drugs
Comparator / control treatment
remain on CNI, dose in relation to CNI-Through levels of 80-180 ng/ml, duration: 1 year, mode of administration: oral capsule
difference between control and intervention group: type of immunosuppressive regime for liver transplant patients ( either CNI treatment or Sirolimus treatment)
at study inclusion, all patients have been on CNI treatment for at least 6 months after liver transplantation
Control group
Active

Outcomes
Primary outcome [1] 240815 0
-renal resistance index assessed by dopplersonography
Timepoint [1] 240815 0
one year following randomisation
Secondary outcome [1] 257485 0
-aortic stiffness measured by pulse plethysmography


-
Timepoint [1] 257485 0
one year following randomisation
Secondary outcome [2] 263672 0
-renal function test: analysis of plasma creatinine levels
Timepoint [2] 263672 0
one year following randomisation
Secondary outcome [3] 263673 0
patient and graft survival
tools: data linkage to medical records
Timepoint [3] 263673 0
one year following randomisation
Secondary outcome [4] 263674 0
-incidence of treated acute rejections
tools: data linkage to medical records
Timepoint [4] 263674 0
one year following randomisation
Secondary outcome [5] 263675 0
-arterial hypertension
test: automatic sphygmomanometer
Timepoint [5] 263675 0
one year following randomisation
Secondary outcome [6] 263676 0
-incidence of hyperlipidemia/ diabetes mellitus
-severity of hyperlipidemia/ diabete mellitus
test: blood analysis of cholesterol and glycosilated hemiglobin
Timepoint [6] 263676 0
one year following randomisation

Eligibility
Key inclusion criteria
-renal of liver allograft recipient
-creatinine clearance > 30ml/min
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- signs of acute rejection

- evidence of active systemic or localised major infection

-known or suspected malignancy ( exception skin malignancies)

- -renal arterial stenosis > 50 % reduction in luminal diameter

-hydronephros

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2070 0
Switzerland
State/province [1] 2070 0

Funding & Sponsors
Funding source category [1] 256705 0
Self funded/Unfunded
Name [1] 256705 0
Address [1] 256705 0
Country [1] 256705 0
Switzerland
Primary sponsor type
Hospital
Name
University Hospital Bern
Address
Department of Nephrology
Freiburgstr. 10
3010 Bern
Country
Switzerland
Secondary sponsor category [1] 256903 0
None
Name [1] 256903 0
Address [1] 256903 0
Country [1] 256903 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Eisenberger U, Sollinger D, Stickel F, Burckhardt B, Frey FJ.
Relationship between Renal Resistance Index and Renal Function in Liver Transplant Recipients after Cessation of Calcineurin Inhibitor.
Clinical Transplantation 2009, 23(4): 499-504
Public notes

Contacts
Principal investigator
Name 30200 0
Address 30200 0
Country 30200 0
Phone 30200 0
Fax 30200 0
Email 30200 0
Contact person for public queries
Name 13447 0
PD Dr. Ute, Eisenberger
Address 13447 0
Senior Resident, Nephrology, University Hospital Bern, Freiburgstr. 10
Country 13447 0
Switzerland
Phone 13447 0
+41 31 6323144
Fax 13447 0
Email 13447 0
ute.eisenberger@insel.ch
Contact person for scientific queries
Name 4375 0
PD Dr. Ute, Eisenberger, ,
Address 4375 0
Senior Resident, Nephrology, University Hospital Bern, Freiburgstr. 10
Country 4375 0
Switzerland
Phone 4375 0
+41 31 6323144
Fax 4375 0
Email 4375 0
ute.eisenberger@insel.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary